Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects
NCT ID: NCT01520831
Last Updated: 2017-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
1999-04-30
2000-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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BIAsp 30
biphasic insulin aspart 30
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
BIAsp 50
biphasic insulin aspart 50
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
BIAsp 70
biphasic insulin aspart 70
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Insulin aspart
insulin aspart
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Interventions
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biphasic insulin aspart 30
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
biphasic insulin aspart 50
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
biphasic insulin aspart 70
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
insulin aspart
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Eligibility Criteria
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Inclusion Criteria
* HbA1c within the normal laboratory range
* Non smoker for at least three months
* Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods
Exclusion Criteria
* Any disease requiring regular use of non topical prescription medicines
* Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
* Any intercurrent illness or endocrine disorders that may affect blood glucose
* Subject with a history of drug or alcohol dependence
* Subject with a first degree relative with diabetes mellitus
* Subject with a history of clinically relevant allergic reactions to medical products
* Subjects who have donated any blood or plasma in the past 3 month preceding screening
18 Years
40 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Neuss, , Germany
Countries
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References
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Heise T, Kapitza C, Jacobsen LV, Brøndsted L, Heinemann L. Pharmacokinetic and pharmacodynamic differences between premixed suspensions of insulin aspart: biphasic insulin aspart 30, 50 and 70. Diabetologia 2005; 48 (Suppl. 1): A301
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1086
Identifier Type: -
Identifier Source: org_study_id
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